ARRY - 520/614 ASH CC notes
1. Squarer on two separate occasions mentioned the NVS R&D Day this Thursday and encouraged ARRY investors to listen to hear about forward plans for MEK162.
2. The ARRY-797 late-breaker abstract for the ACR meeting was accepted.
3. Per slide 12, ARRY intends to pursue accelerated approval of ARRY-520 plus dexamethasone in triple-refractory MM patients and intends to pursue a confirmatory study of 520+either bortezomib or carfilzomib in relapsed and refractory MM. Pivotal trial expected to begin in 2013.
4. ARRY hopes for durability north of 4-5 months for 520 in patients with the low AAG biomarker. Koch said 1/3 of MM patients have elevated AAG (i.e., 2/3 of MM patients could conceivably be targeted with 520). ARRY isn't certain if 520 pivotal trial would be solely focused on patients with lower levels of AAG or if ARRY would pursue a dual primary endpoint.
5. Koch is "very enthusiastic" about 520+carfilzomib combo data but deferred to the data that will be presented at the actual ASH meeting.
6. Squarer interestingly (IMHO) metioned that ARRY's relationship with ONXX is "positive" and ONXX/ARRY have had discussions about co-funding and sharing the costs of 520+carfilzomib trials going forward. Squarer reiterated that ARRY still intends to go it alone on 520 and 614 but ARRY may be open to geographies outside the U.S. and Europe. (Does anyone see ONXX as a potential partner, at a minimum, for ARRY in the future provided 520 and/or 614 data pans out? Obviously ONXX has a hem-onc interest. Just thought Squarer's comments here were interesting; don't recall ARRY ever mentioning any discussions with ONXX before.)
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